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Optumrx Brand Pipeline Forecast

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RxOutlook® 3rd Quarter 2018 OptumRx brand pipeline forecast Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug 2018 Possible launch date Eosinophilic FastTrk/ 2018 - SHP-621 budesonide Shire corticosteroid PO Y Y esophagitis Breakthru 2019 human ProMetic/ Ryplazim plasminogen Plasminogen deficiency IV Filed BLA 2H2018 Y Y plasminogen Hematech testosterone Clarus Jatenzo androgen Hypogonadism PO Filed NDA 2H2018 N N (CLR-610) Therapeutics Immune Remune HIV-1 vaccine Response vaccine HIV IM Filed BLA 2H2018 Y Y BioPharma promethazine/ Charleston anti-emetic/ opioid/ Hydexor hydrocodone/ Nausea/ Vomiting/ Pain PO Filed NDA 2H2018 N N Laboratories analgesic acetaminophen Takeda/ lubiprostone lubiprostone chloride channel activator Constipation PO Filed NDA 2H2018 N N Sucampo tacrolimus Filed Astagraf XL (extended- Astellas immunosuppressant Organ transplantation PO 2H2018 Y N sNDA release) Numbrino cocaine HCl Lannett anesthetic Anesthesia TOP Filed NDA 2H2018 N N Parkinson's disease Nuplazid pimavanserin Acadia 5-HT-2A receptor agonist PO InTrial 2H2018 Y N (PD) psychosis selective progesterone Ella ulipristal acetate Allergan Uterine bleeding PO Filed NDA 3Q2018 N N receptor modulator (SPRM) optum.com/optumrx 1 RxOutlook® 3rd Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug Arakoda tafenoquine 60 degrees apoptosis modulator Malaria PO Filed NDA 3Q2018 N N Aquestive AQST-120 clobazam benzodiazepine Seizures PO Filed NDA 3Q2018 N N Therapeutics moxetumomab moxetumomab MedImmune CD22 antigen inhibitor Hairy cell leukemia IV Filed BLA 3Q2018 Y Y pasudotox pasudotox calcitonin gene-related Migraine prevention/ galcanezumab- LY-2951742 Eli Lilly/ Arteaus peptide (CGRP) receptor Cluster headache SC Filed BLA 3Q2018 N N gnlm antagonist prevention oxycodone Pain Remoxy ER mu-opioid receptor agonist Pain PO Filed NDA 8/7/2018 N N extended-release Therapeutics Dr. Reddy's Tentative Zenavod doxycycline tetracyclines Rosacea PO 8/7/2018 N N Laboratories Approval Attention deficit methylphenidate Highland Benjorna CNS stimulant hyperactivity disorder PO Filed NDA 8/8/2018 N N modified-release Therapeutics (ADHD) ALN-TTR02 Alnylam/ Ionis/ (GENZ438027, patisiran RNAi therapeutic Polyneuropathy IV Filed NDA 8/11/2018 Y Y Sanofi/ Tekmira SAR438027) Galafold alpha-galactosidase A (Amigal, HGT- migalastat Amicus/ GSK Fabry disease PO Filed NDA 8/13/2018 Y Y enhancer 3310, AT-1001) Stanate stannsoporfin Mallinckrodt heme oxygenase inhibitor Hyperbilirubemia IM Filed NDA 8/22/2018 Y N loteprednol Dry eyes/ Ocular Inveltys Kala corticosteroid OP Filed NDA 8/24/2018 N N etabonate MPP inflammation Hereditary angioedema DX-2930 lanadelumab Dyax kallikrein inhibitor SC Filed BLA 8/26/2018 Y Y (HAE) IDP-121 tretinoin Valeant retinoid Acne vulgaris TOP Filed NDA 8/27/2018 N N Tetraphase fully synthetic tetracycline eravacycline eravacycline Bacterial infections IV/PO Filed NDA 8/28/2018 Y N Pharmaceuticals antibiotic optum.com/optumrx 2 RxOutlook® 3rd Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug Non-small cell lung PF-06463922 lorlatinib Pfizer tyrosine kinase inhibitor PO Filed NDA 8/29/2018 Y N cancer (NSCLC) Familial ISIS 304801 chylomicronemia (ISIS- volanesorsen Ionis antisense drug SC Filed NDA 8/30/2018 Y Y syndrome (FCS)/ APOCIIIRx) Lipodystrophy Attention deficit SEP-225289 Sumitomo hyperactivity disorder (DSP-225289, dasotraline Dainippon/ triple reuptake inhibitor PO Filed NDA 8/30/2018 N N (ADHD)/ Eating SEP-289) Sunovion disorders damoctocog alfa BAY94-9027 Bayer anithemophilic factor Hemophilia IV Filed BLA 8/31/2018 Y N pegol Non-small cell lung PF-00299804 dacomitinib Pfizer pan-HER inhibitor PO Filed NDA 9/4/2018 Y N cancer (NSCLC) Cutaneous T-cell AMG-761 (KW- Kyowa Hakko CCR-4 chemokine receptor lymphoma (CTCL)/ mogamulizumab IV Filed BLA 9/4/2018 Y Y 0761, KM-8761) Kirin antibody Adult T-cell leukemia- lymphoma (ATCL) calcitonin gene-related TEV-48125 fremanezumab Teva/ Otsuka peptide (CGRP) receptor Migraine prevention SC Filed BLA 9/16/2018 N N antagonist amikacin liposome ALIS inhalation Insmed aminoglycoside Bacterial infections INH Filed NDA 9/28/2018 Y Y suspension Vibex QST (QuickShot testosterone Antares androgen Hypogonadism SC Filed NDA 9/29/2018 N N Testosterone) ArQule/ Daiichi c-Met receptor tyrosine ARQ-197 tivantinib Hepatic cancer PO InTrial 4Q2018 Y N Sankyo kinase inhibitor salmon calcitonin Tarsa/ Unigene Tbria osteoclast inhibitor Osteoporosis PO Filed NDA 4Q2018 N N (TAR01-201) Laboratories optum.com/optumrx 3 RxOutlook® 3rd Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug VRS-317 Versartis/ Short stature/ Growth somavaratan growth hormone analog SC InTrial 4Q2018 Y Y (hGH-XTEN) Amunix hormone deficiency Seysara sarecycline Allergan/ Paratek tetracyclines Acne vulgaris PO Filed NDA 4Q2018 N N Vernalis/ Tris CCP-07 CCP-07 undisclosed Cough and cold PO CRL 4Q2018 N N Pharma FMX-102 minocycline Foamix tetracyclines Impetigo TOP InTrial 4Q2018 N N (FXFM-244) Vernalis/ Tris CCP-08 CCP-08 undisclosed Viral rhinitis PO CRL 4Q2018 Y N Pharma PTK-0796 (MK- 2764, BAY-73- omadacycline Paratek aminomethylcyclines (AMC) Bacterial infections IV/PO Filed NDA 4Q2018 N N 7388, BAY-73- 6944) Nestorone/ Nestorone/ ethinyl progestin/ estrogen receptor Allergan Pregnancy prevention VA Filed NDA 4Q2018 N N ethinyl estradiol estradiol agonist human monoclonal anti-IL-1 Acute coronary ACZ-885 canakinumab Novartis SC Filed BLA 4Q2018 Y N beta antibody syndrome (ACS) Seciera Auven cyclosporine immunosuppressant Dry eyes OP Filed NDA 4Q2018 Y N (OTX-101) Therapeutics Loxo Oncology/ LOXO-101 larotrectinib tyrosine kinase inhibitor Solid tumors/ Sarcoma PO Filed NDA 4Q2018 Y Y Bayer Inbrija levodopa Acorda antiparkinson Parkinson's disease INH Filed NDA 10/5/2018 N N dopamine receptor APD-421 amisulpride Acacia Nausea/ Vomiting IV Filed NDA 10/5/2018 N N antagonist IPI-145 phosphatidylinositol 3 kinase Chronic lymphocytic duvelisib Verastem/ Infinity PO Filed NDA 10/5/2018 Y Y (INK-1197) inhibitor leukemia (CLL) halobetasol IDP-122 Valeant corticosteroid Psoriasis TOP Filed NDA 10/5/2018 N N propionate IONIS-TTRrx Ionis/ Akcea Transthyretin (TTR) inotersen antisense RNA modulator SC Filed NDA 10/6/2018 Y Y (ISIS-TTRRx, Therapeutics amyloidosis/ optum.com/optumrx 4 RxOutlook® 3rd Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug ISIS-420915; Transthyretin (TTR) GSK-2998728) cardiomyopathy doravirine/ non-nucleoside reverse lamivudine/ transcriptase inhibitor Human MK-1439A tenofovir Merck (NNRTI)/ nucleoside reverse immunodeficiency virus PO Filed NDA 10/23/2018 Y N disoproxil transcriptase inhibitor (HIV) fumarate (NRTI)/ NRTI non-nucleoside reverse Human MK-1439 doravirine Merck transcriptase inhibitor immunodeficiency virus PO Filed NDA 10/23/2018 Y N (NNRTI) (HIV) estrogen receptor TX-001HR estradiol/ TherapeuticsMD agonist/progesterone Menopause PO Filed NDA 10/28/2018 N N (TX-12-001HR) progesterone receptor agonist Cutaneous squamous cell carcinoma (CSCC)/ REGN-2810 Regeneron/ programmed death ligand-1 cemiplimab Non-small cell lung IV Filed BLA 10/28/2018 Y N (SAR-439684) Sanofi (PD-L1) inhibitor cancer (NSCLC)/ Basal cell carcinoma (BCC) TRV-130 oliceridine Trevena opioid receptor agonist Pain IV Filed NDA 11/2/2018 N N ARX-04 sufentanil AcelRx opioid analgesic Pain SL Filed NDA 11/3/2018 Y N fluocinolone Durasert Alimera/ pSivida corticosteroid Posterior uveitis INJ Filed NDA 11/5/2018 Y N acetonide Theravance Chronic obstructive TD-4208 long-acting muscarinic revefenacin Biopharma/ pulmonary disease INH Filed NDA 11/13/2018 N N (GSK-1160724) antagonist (LAMA) Mylan (COPD) Zemcolo DNA-dependent RNA rifamycin Cosmo/ Dr. Falk Traveler's diarrhea PO Filed NDA 11/16/2018 N N (Aemcolo) polymerase inhibitor Primary interferon-gamma NI-0501 emapalumab NovImmune SA hemophagocytic IV Filed BLA 11/20/2018 Y Y antagonist lymphohistiocytosis optum.com/optumrx 5 RxOutlook® 3rd Quarter 2018 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug Lambert-Eaton amifampridine BioMarin/ Firdapse potassium channel blocker myasthenic syndrome PO Filed NDA 11/28/2018 Y Y phosphate Catalyst (LEMS) gilteritinib Acute mylegenous ASP-2215 Astellas tyrosine kinase inhibitor PO Filed NDA 11/29/2018 Y Y fumarate leukemia (AML) Primatene HFA epinephrine Amphastar catecholamine Asthma INH Filed NDA Late 2018 N N Acute myeloid leukemia Cyclacel / Daiichi sapacitabine sapacitabine antimetabolite (AML)/ Non-small cell PO InTrial Late 2018 Y Y Sankyo lung cancer (NSCLC) growth hormone Helsinn / Novo Anorexia/ Cachexia FastTrk/ Adlumiz anamorelin secretagogue receptor PO Late 2018 Y N Nordisk (cancer-related) Breakthru (GHSR) agonist brincidofovir Adenovirus/ DNA-directed DNA FastTrk/ CMX-001 hexadecyloxyprop Chimerix Cytomegalovirus PO Late 2018 N Y polymerase inhibitor Breakthru yl ester (CMV)/ Smallpox CEM-101 solithromycin Cempra macrolide Bacterial infections IV/PO CRL Late 2018 N N FastTrk/ BAY-41-6551 amikacin Nektar/
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  • (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub

    (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub

    US 20170172932A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub. Date: Jun. 22, 2017 (54) EARLY CANCER DETECTION AND A 6LX 39/395 (2006.01) ENHANCED IMMUNOTHERAPY A61R 4I/00 (2006.01) (52) U.S. Cl. (71) Applicant: Gholam A. Peyman, Sun City, AZ CPC .......... A61K 9/50 (2013.01); A61K 39/39558 (US) (2013.01); A61K 4I/0052 (2013.01); A61 K 48/00 (2013.01); A61K 35/17 (2013.01); A61 K (72) Inventor: sham A. Peyman, Sun City, AZ 35/15 (2013.01); A61K 2035/124 (2013.01) (21) Appl. No.: 15/143,981 (57) ABSTRACT (22) Filed: May 2, 2016 A method of therapy for a tumor or other pathology by administering a combination of thermotherapy and immu Related U.S. Application Data notherapy optionally combined with gene delivery. The combination therapy beneficially treats the tumor and pre (63) Continuation-in-part of application No. 14/976,321, vents tumor recurrence, either locally or at a different site, by filed on Dec. 21, 2015. boosting the patient’s immune response both at the time or original therapy and/or for later therapy. With respect to Publication Classification gene delivery, the inventive method may be used in cancer (51) Int. Cl. therapy, but is not limited to such use; it will be appreciated A 6LX 9/50 (2006.01) that the inventive method may be used for gene delivery in A6 IK 35/5 (2006.01) general. The controlled and precise application of thermal A6 IK 4.8/00 (2006.01) energy enhances gene transfer to any cell, whether the cell A 6LX 35/7 (2006.01) is a neoplastic cell, a pre-neoplastic cell, or a normal cell.